A recent JAMA report discovered that almost a third of the FDA-approved drugs come, in fact, with a several safety issues. These issues usually turn out a few years after the medication receives the approval. The occurrence of these events is explained by the pressure of the law officials to offer fast drug reviews and introduce them quickly on the market.
Thirty-two percent of FDA-approved drugs come with subsequent safety events
The report analyzed all FDA-approved drugs issued between 2001 and 2010. From a number of 222, 71 drugs had safety events over a period of 4.2 years on average. Afterwards, the medication was either withdrawn from the market, received a special warning on the box that they be life-threatening, or, if they were not life-threatening, only received a special safety communication.
From all these 222 FDA-approved drugs, three of them were removed completely for the market over concerns of cardiovascular events or development of brain conditions. Then, 61 pills received a boxed warning, while 59 only came with safety communications.
Drugs need to be monitored even after their approval
The study was led by Dr. Joseph Ross, general medicine professor at Yale University. He hopes that this report will help the FDA identify those drug features which later develop safety risks. Also, the agency should perform more thorough reviews on medicine and continue their monitoring even after they are released on the market.
However, detecting potential safety risks is not easy. Usually, the FDA-approved drugs undergo trials involving barely 1,000 patients or fewer, which last for six months on average. This period of supervising is much too short to observe any possible risks. Also, the human sample is scarce, as it does not show how the drug might work on the wider population.
Therefore, researchers highlight the importance of continuous monitoring of FDA-approved drugs, even after they are deemed safe and allowed on the market. This way, regulators can make sure that the drug does not come with any safety events, and is efficient for a larger segment of the population.
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